On August 17, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug UGN-103 (mitomycin) for intravesical solution. UGN-103 is a next-generation mitomycin formulation being developed for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). It is built on the clinical and commercial foundation of ZUSDURI (mitomycin) for intravesical solution.

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"The NDA submission for UGN-103 marks another important milestone in advancing our vision to redefine the treatment of urothelial cancers," said Liz Barrett, President and CEO of UroGen. "UGN-103 represents the next evolution in our portfolio and is designed to provide a more streamlined manufacturing process, simplified reconstitution and extended shelf-life of the reconstituted product while leveraging our RTGel technology."

The NDA for UGN-103 is supported by the clinical data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in adult patients with recurrent LG-IR-NMIBC. UGN-103 demonstrated a 77.8% three-month complete response (CR) rate (95% CI: 68.3%, 85.5%) and a 94.5% six-month duration of response (DOR) by Kaplan-Meier estimate (95% CI: 86.1%, 97.9%). Both the three-month CR rate and the DOR observed at six months with UGN-103 in the UTOPIA trial are consistent with those observed in the pivotal ENVISION trial of ZUSDURI. Because these findings are derived from separate clinical studies, no formal cross-trial comparison was performed.

About UGN-103
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for recurrent LG-IR-NMIBC. UGN-103 is designed to reinforce and build on the clinical and commercial foundation of ZUSDURI, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. The program maintains UroGen’s innovative and proven RTGel technology, enabling sustained mitomycin exposure in the bladder, while incorporating next-generation enhancements, including a more streamlined manufacturing process and simplified reconstitution to support improved ease of use in clinical practice. UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property coverage expected to extend into July 2044.

About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the United States every year and of those, an estimated 59,000 are people experiencing recurrence. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about NMIBC at www.BladderCancerAnswers.com.

About UTOPIA
The UTOPIA trial is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in 99 patients across global sites. Enrolled patients received 75 mg of UGN-103 via intravesical instillation in an outpatient setting once weekly for six weeks. The primary endpoint is CR rate at three months, with responders entering a follow-up phase of up to 12 months to assess DOR. For more information on the UTOPIA study, please visit View Source

(Press release, UroGen Pharma, AUG 17, 2026, View Source [SID1234670183])

On August 17, 2026 Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of sapanisertib and serabelisib (PIKTOR) with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI).

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"Fast Track designation for PIKTOR reflects the significant unmet need in advanced endometrial cancer for patients whose disease has progressed despite platinum-based chemotherapy and an immune checkpoint inhibitor," said Anand Parikh, Chief Executive Officer of Faeth Therapeutics. "We believe PIKTOR’s multi-node approach to the PI3K/AKT/mTOR pathway is well suited to this population as our preclinical data suggests that PIKTOR can resensitize patients to chemotherapy."

About PIKTOR

PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. According to published literature, this pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026. PIKTOR is also being evaluated in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April and interim data is anticipated in 2027.

(Press release, Faeth Therapeutics, AUG 17, 2026, View Source [SID1234670184])

On August 17, 2026 AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, reported that the Company received the U.S. Food and Drug Administration (FDA) clearance of IND application for C-CAR039, also known as Prizloncabtagene Autoleucel (Prizlon-cel), an anti-CD20/CD19 bispecific CAR-T, for the treatment of relapsed or refractory (r/r) Large B-cell Lymphoma (LBCL).

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In July 2026, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights relating to C-CAR039. The Company is currently working with the FDA to finalize the protocols for clinical development in third- or later-line LBCL patients previously treated with CAR-T therapies and second-line LBCL patients that are CAR-T therapy treatment naïve.

The program is supported by encouraging long-term clinical data presented at European Society for Blood and Marrow Transplantation (EBMT) in March 2026. Results from 48 patients with r/r B-cell non-Hodgkin lymphoma (B-NHL) enrolled in the Company’s early clinical trials in China demonstrated a favorable safety profile and deep and durable responses, with an overall response rate (ORR) of 91.5% and complete response (CR) rate of 85.1%. Median PFS was 60.1 months at a median follow-up of 53.9 months.

"We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved CAR-T therapies. This population has significant unmet medical needs and C-CAR039 represents a solution. We will also explore the potential of C-CAR039 in early lines of LBCL. We remain confident about the potential of C-CAR039 and are fully committed to accelerating the global development of C-CAR039, leveraging our extensive expertise in cell therapy."

The registrational Phase II clinical trial of C-CAR039 for r/r LBCL in CAR-T therapy naïve patients in China is still ongoing.

(Press release, AbelZeta, AUG 17, 2026, View Source [SID1234670158])

On August 17, 2026 CEL-SCI Corporation (NYSE American: CVM) reported financial results for three months ended June 30, 2026, as well as key recent corporate, commercial, regulatory, and clinical developments for Multikine (Leukocyte Interleukin, Injection)*.

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"This was a quarter of important progress across our clinical, regulatory and commercialization programs as we move Multikine closer to patients," stated CEL-SCI CEO Geert Kersten. "Our recently published peer-reviewed data identified the biomarkers that allow us to prospectively select the patients most likely to benefit from Multikine—the same population in which our Phase 3 study demonstrated a 73% five-year survival rate compared with 45% for standard of care alone. By focusing our 212-patient Confirmatory Registration Study on this biomarker-selected population, we believe we have substantially increased the likelihood of confirming Multikine’s survival benefit and achieving a successful trial outcome. At the same time, our partnership with Amarox is advancing a potential near-term path to commercial availability in Saudi Arabia. With enrollment in our registration study set to commence globally, we believe we have never been better positioned to bring Multikine to patients and advance it toward commercialization."

Clinical and Corporate Developments:

A leading peer-reviewed journal, Oral Oncology , published biomarker selected population and survival data from CEL-SCI’s Phase 3 clinical study, the largest trial of its kind in the world. The article provides scientific evidence supporting the biomarker strategy that forms the foundation for selecting patients in CEL-SCI’s upcoming global Confirmatory Registration Study. Low and zero (0%) tumor PD-L1 expression and no lymph node involvement were identified as biomarkers for selecting patients most likely to benefit from Multikine pre-surgery treatment. The published study concludes that Multikine represents the first neoadjuvant treatment in decades to demonstrate an overall survival benefit in biomarker-selected patients with locally advanced resectable oral cancer. Multikine neoadjuvant treatment also demonstrated a statistically significant improvement in progression-free survival with a 49% reduction in the risk of disease progression in the same biomarker-selected patients.
CEL-SCI is set to commence enrollment in its 212-patient U.S. FDA Confirmatory Registration Study evaluating Multikine in newly diagnosed, locally advanced head and neck cancer patients at clinical sites in the U.S., Europe, Asia and South America. Because Multikine is administered for a short period before surgery, pre-surgical tumor responses can be evaluated within weeks following full enrollment, providing an early assessment of Multikine’s anti-tumor activity. CEL-SCI plans to use these early tumor response data to pursue potential accelerated approval in the U.S. while patients continue to be followed for overall survival.
CEL-SCI entered a strategic partnership with Amarox , one of Saudi Arabia’s fastest growing pharmaceutical companies to pursue regulatory approval, marketing and commercialization of Multikine for head and neck cancer in Saudi Arabia, with an optional extension for the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates. Amarox will support and coordinate the regulatory process with the Saudi Food and Drug Authority (SFDA), including pursuit of Breakthrough Medicine Designation—the granting of which could lead to immediate availability of Multikine for reimbursement/sale in Saudi Arabia. Amarox has ranked #1 for SFDA applications for critical and unavailable medicines for 3 consecutive years. CEL-SCI and Amarox will share net revenue from Saudi Arabian Multikine sales on a 50%/50% basis.
Gross proceeds of approximately $9.7 million were raised by CEL-SCI during the quarter.
Financial Results

During the three months ended June 30, 2026, research and development expenses were $3.6 million compared to $3.7 million for the three months ended June 30, 2025. General and administrative expenses for the three months ended June 30, 2026 were $1.9 million compared to $1.7 million for the three months ended June 30, 2025. Cash used for operating activities during the three months ended June 30, 2026 was $4.0 million. Net loss was $5.7 million for the three months ended June 30, 2026, unchanged from the second quarter of 2025. Basic and diluted net loss per common share was $0.47 for the three months ended June 30, 2026, compared to $1.36 for the three months ended June 30, 2025.

About Multikine

Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

(Press release, Cel-Sci, AUG 17, 2026, View Source;storyId=5803345550585143 [SID1234670185])

On August 17, 2026 OmniAb, Inc. (NASDAQ: OABI), a provider of cutting-edge discovery research technology to enable the discovery of next-generation therapeutics, reported a global collaboration and license agreement with Eli Lilly and Company (Lilly) for a new ion channel program. The collaboration leverages OmniAb’s technology platform and expertise in ion channel discovery and screening.

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"We are pleased to enter into this important new relationship with Lilly," said Matt Foehr, OmniAb’s Chief Executive Officer. "Lilly is focused on delivering medicines to address major unmet medical needs and our differentiated expertise and established technologies that relate to ion channels are well positioned to help drive this new discovery program."

Under the terms of the agreement, OmniAb will receive an upfront payment and is eligible to receive up to $370 million in research, development, and commercial milestone payments, as well as tiered royalties on global net sales. The therapeutic target and modality are undisclosed.

(Press release, OmniAb, AUG 17, 2026, View Source;Company/default.aspx [SID1234670186])